Safety Study of OPC-12759 Ophthalmic Solutio
Phase 1
Completed
- Conditions
- Dry eye syndromes
- Registration Number
- JPRN-jRCT2080221632
- Lead Sponsor
- Otsuka Pharmaceuticals Co., Ltd.
- Brief Summary
2% OPC-12759 ophthalmic solution had no particular safety problems in the treatment for dry eye.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
1.Gender: Male or Female
2.Age: 20 years and older (at the time of informed consent)
3.BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2
Exclusion Criteria
1.Presence of ocular disorder
2.Intraocular pressure of 21mmHg or higher
3.Corrected visual acuity of less than 1.0
4.Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
5.History of refractive surgery
6.History of other ocular surgeries within 12 months
7.Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>The occurrences of blurred vision and dysgeusia
- Secondary Outcome Measures
Name Time Method